MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure, date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient comorbidities / concomitant medications? product code and lot number? the initial approach for the index surgical procedure? any concurrent procedure / device implantation? were there any intra-operative complications? when was the mesh erosion first noted by a physician? mesh exposure site / location, symptoms and diagnostic confirmation? describe any medical / surgical intervention for mesh erosion and severe pain including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event? (mesh erosion and severe pain)? what is the patient's current status?.

Event Description

It was reported that the patient underwent a gynecological procedure on unknown date and the mesh was implanted.The patient experienced severe lower pelvic pain and erosion causing pain.The patient is unable to have intercourse.The device remains implanted.Additional information has been requested.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8952305
• MDR Text Key: 156498417
• Report Number: 2210968-2019-86456
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention